| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00174-1 |
| Product Name/Description |
OPMI Pentero surgical microscope system (PC 2.1)
Manufactured from December 8, 2006 to October 5, 2010
Serial Numbers: 6631402471 to 6631461774
ARTG Number: 187127 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Based on post-market surveillance of hardware system performance, it has been identified that system components may cause, in rare situations, a blocking of the magnetic brakes or a system freeze/ system restart during operation potentially prolonging surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carl Zeiss is providing a software and hardware update to ensure the malfunction does not occur. An enhanced long-term software and hardware maintenance of the OPMI Pentero system procedure is also included in the maintenance package. This action has been closed-out on 28/01/2016 |
| Contact Information |
1300 367 244 - Carl Zeiss Head Office Service |